MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT

Model Number	LS14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	04/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2013.Dilation performed on (b)(6) 2016 prior to explant.Tests prior to device explant showed no reflux and no motility disorder.Patient declined further physician recommended investigation and requested the device be removed.Uneventful device explant due to severe dysphagia on (b)(6) 2016.Linx device found in the correct position/geometry.
Additional Manufacturer Narrative
The reason for explant was initially reported to torax medical as severe dysphagia.Upon further follow-up dr.(b)(6) clarified that the initial complaint form incorrectly checked the severe dysphagia box and should have checked the mild dysphagia box instead.Dr.(b)(6) also specified the type of dysphagia as oral-pharyngeal.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2013.Dilation performed on (b)(6) 2016 prior to explant.Tests prior to device explant showed no reflux and no motility disorder.Patient declined further physician recommended investigation and requested the device be removed.Uneventful device explant due to mild oral-pharyngeal dysphagia on (b)(6) 2016.Linx device found in the correct position/geometry.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 5645277
• Report Number: 3008766073-2016-00036
• Device Sequence Number: 219383
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 06/27/2016
• Device Model Number: LS14
• Device Lot Number: 3700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 07/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Age: 34 YR
• Patient Weight: 52